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NCT Number: NCT06917300

Virtual Reality as a Digital Premed to Alleviate Pain and Anxiety Preoperatively in Patients Undergoing Spine Surgery

The aim of this research study is to evaluate the impact of immersive VR exposure on preoperative anxiety and pain. Additionally, to assess whether VR intervention would significantly alleviate pain and anxiety levels of patients undergoing complex spinal surgeries. Investigators hypothesize that the application of pre-operative VR-based intervention will alleviate anxiety and pain both pre- and post-operatively when it is used as treatment to complement standard care compared to standard routine care alone, and that it may lead to better outcomes and higher satisfaction in patients.

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Key information

Conditions

Anxiety and Fear Anxiety Disorders Mental Disorders Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms Stress

Age range

25 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Redwan Rahman Jabbar

Lodz, Łódź Voivodeship, 90-549, Poland

Location status: Recruiting

Location contact

Redwan Jabbar, MD

PRINCIPAL_INVESTIGATOR

Redwan Jabbar, MD, PhD (Candid.)

CONTACT

[email protected]

0048570940828

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult patients between 25-70 years old, undergoing an elective spinal surgery.
  • Patient's admission prior to surgery day (at least 1 day).
  • Expected hospital stay - 2 days.
  • Capable of providing informed consent and participate in the study follow-up questionnaire.
  • Patients speak Polish.

Exclusion criteria

  • Congestive heart failure, hypertension and anti-hypertensive medications
  • Adrenal insufficiency
  • Alcohol addiction (evaluated by CAGE/AUDIT) and substance addiction (evaluated by DUDIT)
  • Cognitive impairment (evaluated by MMSE, MoCA)
  • Cerebrovascular diseases, ophthalmological diseases (strabismus, diplopia, retina degeneration, glaucoma), neurological conditions (epilepsy or seizure, dementia, vertigo, dizziness, motion sickness) - evaluated by: history taking, examination, vision test (Ishihara test), Simulator Sickness Questionnaire
  • Auditory impairment
  • Psychiatric illness (schizophrenia, bipolar disorder, psychotic depression) - (evaluated by MINI questionnaire)
  • Patients with neuropathic pain
  • Use of sedative drugs, anti-depressants, anxiolytics, and anti-epileptic drugs
  • Intracranial functional lesions (patients after TBI (Traumatic Brain Injury), cognitive or executive dysfunction)
  • Patient with high risk due to major and emergency operations
  • Claustrophobia
  • GCS < 15

Treatment and study plan

Virtual reality

Device

The VR group will be exposed to a unified 15-minute VR video via phone using a VR device and goggles after receiving routine standard care. A 360˚ video with an immersive audio-visual environment describing pre-operative and post-operative experience on the day of the surgery will be provided, by which they can get accustomed to the environment and procedures associated with the surgery. Background audio will be provided through headsets, and the video will be directed by a neurosurgeon filmed using a Max 360 action VR camera. In the video, actors, neurosurgeons, and nurses will re-enact a typical day for a mock patient undergoing surgery, plus routine post-operative care, including the post-operative immediate recovery room and rehabilitation care by neurosurgeons, psychologists, and physiotherapists in the ward. Patients are allowed to move around freely so that they can experience all aspects of the virtual space, and are encouraged to ask questions at the end.

Primary outcomes

  1. Stress (STAI-S) and Pain (VAS)

    Time frame: 24 hours postoperatively

    The Primary outcome for this trial is the change in the intensity of pre-operative anxiety measured by the State-Trait Anxiety Inventory (STA-I) scale and pain measured by visual Analogue Scale (VAS). These outcomes will be measured pre-operatively on the day before surgery. Measurements will be made again post-operatively - within 24 hours. Pre-operative and post-operative STAI-S and VAS will be compared for data analysis.

Secondary outcomes

  1. Satisfaction (EVAN-G) and Postoperative Stress (PSS-10)

    Time frame: 24 hours postoperatively

    The Secondary outcome will be the patients' quality of life and satisfaction measured by Evaluation du Vecu de l'Anesthesie Generale (EVAN-G) questionnaire and postoperative stress measured by Perceived Stress Scale PSS-10 within 24 hours and used for data analysis, since the level of satisfaction and the stress caused by thinking time spent at pain can contribute to an increased perception of pain.

Study contacts

Contact information is provided by the study sponsor or research team.

Redwan Jabbar, MD, PhD (Candid.)

CONTACT

[email protected]

0048570940828

Sponsors and collaborators

Lead sponsor

Medical University of Lodz

Other

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Apr 8, 2025
Registry last updated
Apr 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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